HGSI - Why Im confident
After reading the briefing document over and over, i can honestly say that i am still very happy to hold my shares in HGSI.
The FDA clearly states that there is a need for effective therapies of which there is none currently.They acknowledge that benlysta is effective for some race of people over time and that clinical trials have certainly proved this.
Here is part of the FDA meeting and HGSI on Tuesday morning (ALL IN MY OWN WORDS OF COURSE )
HGSI - "Mr/Mrs Rheumatologists, basically if what you are telling us, Benlysta is not 100% safe or effective and that possibly would cause you to VOTE NO? If so, can you tell us a drug that is 100% safe or effective? Drugs have been cleared by the FDA to meet the needs of 100"s and 1000's of ailments, before and during our lifetimes. Each of these drugs/medications etc.. are not the 100% answer to EVERY PATIENTS disease. Our point is, Benlysta like any other medication, might not have 100% efficacy for ALL patients as per your findings. You have found that Benlysta has done more that any other treatment has for the last 50years and beyond. It certainly has shed the light and has shown TREMENDOUS progress with patients along with opening the door for this medication along with many other added therapies to help increase the day to day lifestyle of millions of individuals. By no means are we saying to approve Benlysta because there is no other hope. What we are saying is that you need to approve Benlysta to not only provide hope, but to shed the light on the pharmaceutical industry across the board - that this medication is the start of something major for millions of lupus sufferers.
Like any other medication, there has to be advancements over time due to the ever changing lifestyle/effectiveness/population and this is where it should begin.
Panel : TBD
Suicide ??? Talk to someone with Lupus about how debilitating the pain can be. Suicidal thoughts are for real whether they have taken a medication or not - Don't you think HGSI is ready to meet this concern rather easily.
HGSI - "Mr/Mrs. rheumatologist, does this Panel truly believe that these patients ALL OF A SUDDEN have suicidal thoughts? Can you honestly tell us, this panel, or any one of the millions of people with this debilitating disease that you believe that these suicidal deaths had everything to do with this medication and NOT with the pain and suffering that they have to do deal with all of their life?
Panel - TBD
If you don't think HGSI can explain this to the panel, if you don't think the reward outweigh the risks, if you don't believe that the FDA has enough information on their hands to change the way we look at Lupus, then obviously, don't invest here,
I for one, am a big believer in HGSI and what this company will do to help many people in need, TODAY!!!
All of these statements are all my opinion and please do your own DD and invest wisely.
Good luck if you are invested here or plan on taking a long position now or in the future.
As always, good luck in whatever investments you are in.
GN
